The Journal of infection · 2014
Bead-based multiplex sexually transmitted infection profiling.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Schmitt Markus, Depuydt Christophe, Stalpaert Michel, Pawlita Michael
Аннотация
OBJECTIVES: Sexually transmitted infections are a significant cause of genital disease, infertility and hospital admissions. The economic impact is high. An accurate diagnosis is often difficult and time consuming. We report the development and validation of a novel bead-based multiplex sexually transmitted infection profiling (STIP) assay that detects 18 sexually transmitted infections using a multiplex PCR followed by Luminex bead-based hybridisation.
METHODS: STIP was validated using urogenital samples pretested by commercially available quantitative PCR, microscopy or by culturing methods.
RESULTS: STIP specifically detects Chlamydia trachomatis, Herpes simplex virus 1 and 2, Treponema pallidum, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma (M.) genitalium, M. hominis, M. pneumonia, M. spermatophilum, Ureaplasma urealyticum and U. parvum, and quantifies bacterial vaginosis-associated Atopobium vaginae and Gardnerella vaginalis as well as three Candida species and normal genital flora-associated Lactobacillus species. STIP reached an overall concordance of 95-100% with commercially available quantitative PCR tests. Compared to Nugent score, STIP reached a sensitivity of 95% and a specificity of 86% for bacterial vaginosis detection. Candida specimens, pretested by direct culturing, were identified with a sensitivity of 97% and a specificity of 99%.
CONCLUSIONS: STIP is a powerful high-throughput tool in assessing a broad spectrum of urogenital infections.
METHODS: STIP was validated using urogenital samples pretested by commercially available quantitative PCR, microscopy or by culturing methods.
RESULTS: STIP specifically detects Chlamydia trachomatis, Herpes simplex virus 1 and 2, Treponema pallidum, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma (M.) genitalium, M. hominis, M. pneumonia, M. spermatophilum, Ureaplasma urealyticum and U. parvum, and quantifies bacterial vaginosis-associated Atopobium vaginae and Gardnerella vaginalis as well as three Candida species and normal genital flora-associated Lactobacillus species. STIP reached an overall concordance of 95-100% with commercially available quantitative PCR tests. Compared to Nugent score, STIP reached a sensitivity of 95% and a specificity of 86% for bacterial vaginosis detection. Candida specimens, pretested by direct culturing, were identified with a sensitivity of 97% and a specificity of 99%.
CONCLUSIONS: STIP is a powerful high-throughput tool in assessing a broad spectrum of urogenital infections.